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Check out JobsAILeads the Clinical Development Team
Leads the Clinical Development (CD) Team, a cross-functional, multinational team of internal experts, through clinical phase II – III trials, global product registration, and supporting product lifecycle optimization. Sets project-related objectives with Global Project Team (GPT) members and provides input for their annual performance evaluations. Coordinates resource availability with global functional heads.
- Member of the Global Project Team and the Global Brand team, representing CD
- Prepares the Clinical Development Plan (CDP), including operational plans with timelines, budget, and manpower estimates.
- Manages clinical timelines, budgets (external grants and CRO fees), and manpower, initiating corrective actions as needed.
- Performs ongoing risk-benefit assessments of compounds until approval, analyzing clinical data and scientific information.
- Communicates study strategies, results, and project updates to internal and external stakeholders, including regulatory authorities.
- Prepares and maintains regulatory documents such as Investigators’ Brochures and briefing documents.
- Provides medical expertise to marketing teams, defines publication strategies, and approves publications ensuring data consistency.
- Establishes external scientific advisory boards and supports advocacy development.
- Assesses in- and out-licensing opportunities, promotes patient-centric trial designs, and involves patients in planning.
- Ensures domestic study concepts align with global strategies.
Qualifications
- Medical degree (M.D.) with extensive professional and academic experience
- Board certification in Neurology
- 7+ years in clinical research and drug development, with a focus on neurology
- 3+ years managing neurodegenerative disease programs in biotech
- Experience with registration trials and regulatory submissions preferred
- Strategic thinker with independence, accuracy, resilience, and creativity
- Proven leadership, motivation, and interpersonal skills
- Self-initiator capable of working in international teams
- Excellent English communication skills
Additional Expertise and Skills
- Experience in biotech environments, especially drug registration
- Direct regulatory agency interaction experience
- Cultural adaptability between German and American work styles
- Innovative, solutions-oriented, and open-minded approach
Benefits of Working in ICON
We prioritize our people’s success by offering competitive salaries, performance bonuses, comprehensive health benefits, retirement plans, and a supportive environment that fosters purpose and change. ICON is committed to diversity and inclusion, providing equal employment opportunities and accommodations for disabilities or medical conditions.